Medical device adjusting operation when used with non-authenticated patient parameter collecting accessory

ABSTRACT

Embodiments are directed to a medical device, such as a defibrillator, for use with an accessory capable of collecting a parameter of a patient. The medical device is capable of at least performing a basic functionality, an advanced functionality, and of defibrillating the patient. The medical device includes an energy storage module within a housing for storing an electrical charge that is to be delivered to the patient for the defibrillating. The medical device includes a processor structured to determine whether a data set received from the accessory confirms or not a preset authentication criterion about the accessory. Although when the accessory is coupled to the housing the medical device is capable of the defibrillating and the basic functionality, the medical device is capable of the advanced functionality only when the accessory is coupled to the housing and it is determined that the preset authentication criterion is confirmed. Embodiments also include methods of operation and a programmed solution.

CROSS REFERENCE TO RELATED PATENT APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 14/678,742, filed Apr. 3, 2015, entitled MEDICAL DEVICEADJUSTING OPERATION WHEN USED WITH NON-AUTHENTICATED PATIENT PARAMETERCOLLECTING ACCESSORY, currently pending, which is a continuation of U.S.patent application Ser. No. 13/445,776, filed Apr. 12, 2012, entitledMEDICAL DEVICE ADJUSTING OPERATION WHEN USED WITH NON-AUTHENTICATEDPATIENT PARAMETER COLLECTING ACCESSORY, issued as U.S. Pat. No.9,008,766, which is a continuation-in-part of U.S. patent applicationSer. No. 12/760,331, filed Apr. 14, 2010, entitled SELECTIVE POWERING OFMEDICAL DEVICE DEPENDING ON AUTHENTICATION OF POWER ADAPTER SYSTEM,issued as U.S. Pat. No. 8,183,823. The U.S. Ser. No. 13/445,776application is a continuation-in-part application of U.S. patentapplication Ser. No. 12/760,378, filed Apr. 14, 2010, entitled SELECTIVERECHARGING OF MEDICAL DEVICE DEPENDING ON AUTHENTICATION OF POWERADAPTER SYSTEM, issued as U.S. Pat. No. 8,179,087.

Both U.S. patent application Ser. Nos. 12/760,331 and 12/760,378 arecontinuations-in-part of U.S. patent application Ser. No. 12/131,267,entitled DEFIBRILLATOR BATTERY AUTHENTICATION SYSTEM filed on Jun. 2,2008, which is now U.S. Pat. No. 7,728,548. All of the above-referencedpatents and patent applications are incorporated by reference herein.

FIELD

This invention generally relates to medical devices and accessories forthem.

BACKGROUND

In humans, the heart beats to sustain life. In normal operation, itpumps blood through the various parts of the body. More particularly,the various chamber of the heart contract and expand in a periodic andcoordinated fashion, which causes the blood to be pumped regularly. Morespecifically, the right atrium sends deoxygenated blood into the rightventricle. The right ventricle pumps the blood to the lungs, where itbecomes oxygenated, and from where it returns to the left atrium. Theleft atrium pumps the oxygenated blood to the left ventricle. The leftventricle, then, expels the blood, forcing it to circulate to thevarious parts of the body. The heart chambers pump because of theheart's electrical control system. More particularly, the sinoatrial(SA) node generates an electrical impulse, which generates furtherelectrical signals. These further signals cause the above-describedcontractions of the various chambers in the heart, in the rightsequence. The electrical pattern created by the sinoatrial (SA) node iscalled a sinus rhythm.

Sometimes, however, the electrical control system of the heartmalfunctions, which can cause the heart to beat irregularly, or not atall. The cardiac rhythm is then generally called an arrhythmia, and someof it may be caused by electrical activity from locations in the heartother than the SA node. Some types of arrhythmia may result ininadequate blood flow, thus reducing the amount of blood pumped to thevarious parts of the body. Some arrhythmias may even result in a SuddenCardiac Arrest (SCA). In a SCA, the heart fails to pump bloodeffectively, and death can occur. In fact, it is estimated that SCAresults in more than 250,000 deaths per year in the United States alone.Further, a SCA may result from a condition other than an arrhythmia.

One type of arrhythmia associated with SCA is known as VentricularFibrillation (VF). VF is a type of malfunction where the ventricles makerapid, uncoordinated movements, instead of the normal contractions. Whenthat happens, the heart does not pump enough blood. The person'scondition will deteriorate rapidly and, if not reversed in time, theywill die soon, e.g. within ten minutes.

Ventricular Fibrillation can often be reversed using a life-savingdevice called a defibrillator. A defibrillator, if applied properly, canadminister an electrical shock to the heart. The shock may terminate theVF, thus giving the heart the opportunity to resume pumping blood. If VFis not terminated, the shock may be repeated, often at escalatingenergies.

A challenge with defibrillation is that the electrical shock must beadministered very soon after the onset of VF. There is not much time:the survival rate of persons suffering from VF decreases by about 10%for each minute the administration of a defibrillation shock is delayed.After about 10 minutes the rate of survival for SCA victims averagesless than 2%.

The challenge of defibrillating early after the onset of VF is being metin a number of ways. First, for some people who are considered to be ata higher risk of VF or other heart arrythmias, an ImplantableCardioverter Defibrillator (ICD) can be implanted surgically. An ICD canmonitor the person's heart, and administer an electrical shock asneeded. As such, an ICD reduces the need to have the higher-risk personbe monitored constantly by medical personnel.

Regardless, VF can occur unpredictably, even to a person who is notconsidered at risk. As such, VF can be experienced by many people wholack the benefit of ICD therapy. When VF occurs to a person who does nothave an ICD, they collapse, because blood flow has stopped. They shouldreceive therapy quickly.

For a VF victim without an ICD, a different type of defibrillator can beused, which is called an external defibrillator. External defibrillatorshave been made portable, so they can be brought to a potential VF victimquickly enough to revive them.

During VF, the person's condition deteriorates, because the blood is notflowing to the brain, heart, lungs, and other organs. Blood flow must berestored, if resuscitation attempts are to be successful.

Cardiopulmonary Resuscitation (CPR) is one method of forcing blood flowin a person experiencing cardiac arrest. In addition, CPR is the primaryrecommended treatment for some patients with some kinds of non-VFcardiac arrest, such as asystole and pulseless electrical activity(PEA). CPR is a combination of techniques that include chestcompressions to force blood circulation, and rescue breathing to forcerespiration.

Properly administered CPR provides oxygenated blood to critical organsof a person in cardiac arrest, thereby minimizing the deterioration thatwould otherwise occur. As such, CPR can be beneficial for personsexperiencing VF, because it slows the deterioration that would otherwiseoccur while a defibrillator is being retrieved. Indeed, for patientswith an extended down-time, survival rates are higher if CPR isadministered prior to defibrillation.

Proper treatment and cure of patients oftentimes includes using medicaldevices. Many of these medical devices, such as defibrillators, useaccessories. These accessories are typically replaced more often thanthe device itself, for example due to wear. Other accessories areintended to be used for only one patient, and are therefore replacedeach time the medical device is used with a new patient.

Accessories are typically produced by either the device manufacturer ora party authorized by the device manufacturer. These accessories aremade to exacting standards to work properly with the device. Somecompanies may make accessories that are not authorized by the devicemanufacturer but still may work with the device. These accessories areknown as unauthorized accessories. Sometimes unauthorized accessoriesare made to lower quality standards than authorized accessories. Due tothis lower quality, some unauthorized accessories can cause the deviceto not function as well, or even cause it to malfunction, both of whichmay compromise patient care. Oftentimes, users may not be able todistinguish between authorized and un-authorized accessories becausesome unauthorized accessories are produced and marked to appear asauthorized accessories. Thus, there is no way to tell from looking at anaccessory whether it will operate properly, in the case of an authorizedaccessory, or may comprise patient care, in the case of an unauthorizedaccessory.

Embodiments of the invention address these and other limitations of theprior art.

BRIEF SUMMARY

The present description gives instances of devices, systems, softwareand methods, the use of which may help overcome problems and limitationsof the prior art.

Embodiments include a medical device for use with an accessory capableof collecting a parameter of a patient, the medical device capable of atleast a basic functionality, an advanced functionality, and ofdefibrillating the patient. The device includes a housing structured tocouple with the accessory and an energy storage module within thehousing for storing an electrical charge that is to be delivered to thepatient for the defibrillating. The device also includes a processor inthe housing structured to determine whether a data set received from theaccessory confirms or not a preset authentication criterion about theaccessory. When the accessory is coupled to the housing, the medicaldevice is capable of the defibrillating and the basic functionality. Themedical device is additionally capable of the advanced functionalityonly when the accessory is coupled to the housing and it is determinedthat the preset authentication criterion is confirmed.

Other embodiments include a method in a medical device for use with anaccessory capable of collecting a parameter of a patient and capable ofat least a basic functionality, an advanced functionality, and ofdefibrillating the patient. The method includes enabling thedefibrillating ability of the medical device, enabling the basicfunctionality of the medical device, and enabling the advancedfunctionality of the medical device. After the accessory is coupled tothe medical device, the method determines whether a data set receivedfrom the accessory confirms or not a preset authentication criterionabout the coupled accessory. The method also disables the advancedfunctionality of the medical device after it is determined that thepreset authentication criterion is not confirmed about the coupledaccessory.

An advantage over the prior art is that users of such devices can besecure knowing that patient care is not being compromised by usingunauthorized, and perhaps inferior, accessories.

In some embodiments, critical functionality of the medical device is notput at risk due to operation with a faulty, unauthorized accessory. Insome embodiments, operators of a medical device are informed early whenunauthorized accessories are coupled to the device, alerting suchoperators of the possibility of compromised patient care. In someembodiments, when the advanced functionality is blocked, operators areinformed before such functionality is medically necessary.

These and other features and advantages of this description will becomemore readily apparent from the following Detailed Description, whichproceeds with reference to the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram of a scene where an external defibrillator is usedto save the life of a person according to embodiments.

FIG. 2 is a table listing two main types of the external defibrillatorshown in FIG. 1 , and who they might be used by.

FIG. 3 is a block diagram of an external defibrillator medical devicemade according to embodiments, before an accessory has been attached.

FIG. 4 is a block diagram of the medical device of FIG. 3 , after anauthorized accessory has been attached.

FIG. 5 is a block diagram of the medical device of FIG. 3 , afteranother authorized accessory has been attached, using a differentattachment method than in FIG. 4 .

FIG. 6A is a block diagram of the medical device of FIG. 3 , after anexample unauthorized accessory has been attached.

FIG. 6B is a block diagram of the medical device of FIG. 3 , afteranother example unauthorized accessory has been attached.

FIG. 6C is a block diagram of the medical device of FIG. 3 , after onemore example unauthorized accessory has been attached.

FIG. 7 is a conceptual diagram for explaining an operation of themedical device of FIG. 3 .

FIG. 8 is a detailed block diagram of an example external defibrillator,such as that shown in FIG. 3 , showing additional components that may beincluded according to embodiments.

FIG. 9 is a detailed flow diagram illustrating example methods accordingto embodiments of the invention.

DETAILED DESCRIPTION

As has been mentioned, the present description is about medical devices,methods of operating such medical devices, and a programmed processor tocontrol such medical devices for controlling enabling features of themedical device based on a determination of whether an authorizedaccessory is attached.

Embodiments are now described in more detail.

FIG. 1 is a diagram of a defibrillation scene. A person 82 is lying ontheir back. Person 82 could be a patient in a hospital, or someone foundunconscious, and then turned to be on their back. Person 82 isexperiencing a condition in their heart 85, which could be VentricularFibrillation (VF).

A portable external defibrillator 100 has been brought close to person82. At least two defibrillation electrodes 104, 108 are usually providedwith external defibrillator 100, and are sometimes called electrodes104, 108. Electrodes 104, 108 are coupled with external defibrillator100 via respective electrode leads 105, 109. A rescuer (not shown) hasattached electrodes 104, 108 to the skin of person 82. Defibrillator 100is administering, via electrodes 104, 108, a brief, strong electricpulse 111 through the body of person 82. Pulse 111, also known as adefibrillation shock, goes also through heart 85, in an attempt torestart it, for saving the life of person 82.

Defibrillator 100 can be one of different types, each with differentsets of features and capabilities. The set of capabilities ofdefibrillator 100 is determined by planning who would use it, and whattraining they would be likely to have. Examples are now described.

FIG. 2 is a table listing two main types of external defibrillators, andwho they are primarily intended to be used by. A first type ofdefibrillator 100 is generally called a defibrillator-monitor, becauseit is typically formed as a single unit in combination with a patientmonitor. A defibrillator-monitor is sometimes calledmonitor-defibrillator. A defibrillator-monitor is intended to be used bypersons in the medical professions, such as doctors, nurses, paramedics,emergency medical technicians, etc. Such a defibrillator-monitor isintended to be used in a pre-hospital or hospital scenario.

As a defibrillator, the device can be one of different varieties, oreven versatile enough to be able to switch among different modes thatindividually correspond to the varieties. One variety is that of anautomated defibrillator, which can determine whether a shock is neededand, if so, charge to a predetermined energy level and instruct the userto administer the shock. Another variety is that of a manualdefibrillator, where the user determines the need and controlsadministering the shock.

As a patient monitor, the device has features additional to what isminimally needed for mere operation as a defibrillator. These featurescan be for monitoring physiological indicators of a person in anemergency scenario. These physiological indicators are typicallymonitored as signals. For example, these signals can include a person'sfull ECG (electrocardiogram) signals, or impedance between twoelectrodes. Additionally, these signals can be about the person'stemperature, non-invasive blood pressure (NIBP), arterial oxygensaturation/pulse oximetry (SpO2), the concentration or partial pressureof carbon dioxide in the respiratory gases, which is also known ascapnography, and so on. These signals can be further stored and/ortransmitted as patient data.

A second type of external defibrillator 100 is generally called an AED,which stands for “Automated External Defibrillator”. An AED typicallymakes the shock/no shock determination by itself, automatically. Indeed,it can sense enough physiological conditions of the person 82 via onlythe shown defibrillation electrodes 104, 108 of FIG. 1 . In its presentembodiments, an AED can either administer the shock automatically, orinstruct the user to do so, e.g. by pushing a button. Being of a muchsimpler construction, an AED typically costs much less than adefibrillator-monitor. As such, it makes sense for a hospital, forexample, to deploy AEDs at its various floors, in case the moreexpensive defibrillator-monitor is more critically being deployed at anIntensive Care Unit, and so on.

AEDs, however, can also be used by people who are not in the medicalprofession. More particularly, an AED can be used by many professionalfirst responders, such as policemen, firemen, etc. Even a person withonly first-aid training can use one. And AEDs increasingly can supplyinstructions to whoever is using them.

AEDs are thus particularly useful, because it is so critical to respondquickly, when a person suffers from VF. Indeed, the people who willfirst reach the VF sufferer may not be in the medical professions.

Increasing awareness has resulted in AEDs being deployed in public orsemi-public spaces, so that even a member of the public can use one, ifthey have obtained first aid and CPR/AED training on their owninitiative. This way, defibrillation can be administered soon enoughafter the onset of VF, to hopefully be effective in rescuing the person.

There are additional types of external defibrillators, which are notlisted in FIG. 2 . For example, a hybrid defibrillator can have aspectsof an AED, and also of a defibrillator-monitor. A usual such aspect isadditional ECG monitoring capability.

FIG. 3 is a block diagram of an external defibrillator medical devicemade according to embodiments, before an accessory has been attached. Amedical device 300 may use an accessory 477 capable of collecting aparameter of a patient, such as the patient 82 of FIG. 1 . The medicaldevice 300 is capable of at least a basic functionality 352, an advancedfunctionality 353, and of defibrillating the patient 351. The medicaldevice 300 includes a housing 301 structured to couple with theaccessory 477. The medical device 300 also includes an energy storagemodule 350 within the housing 301 for storing an electrical charge thatis to be delivered to the patient for the defibrillating of the patient.Also within the housing 301 of the medical device 300 is a processor 330structured to determine whether a data set 479 received from theaccessory 477 confirms or not a preset authentication criterion aboutthe accessory. This authentication criterion is used by the medicaldevice 300 to determine if the accessory 477 is an authorized accessory,and, based on the determination of whether an authorized accessory isattached or coupled to the medical device, set a level of services orcause other actions to occur.

The accessory 477 includes a data storage device 478, which stores anaccessory data set 479. The data set 479 may be read by the medicaldevice 300, as described below, and a determination made from the dataset used to set a level of functionality for the medical device. Thedata storage device 478 may be, for example, a non-volatile memorydevice, such as a PROM, EPROM, or Flash memory. In other embodiments thedata storage device 478 may be an RFID (Radio Frequency Identification)tag, bar code, etc. Similarly, the reader 392 may be structured howevernecessary to read the data set 479, 579 from the data storage device478, 578. For example, the reader 392 may be an RFID reader, a bar codereader, an infrared reader, or a set of instructions in the processor330.

FIG. 4 is a block diagram of the medical device of FIG. 3 after anauthorized accessory has been attached or coupled to it, while FIG. 5 isa block diagram of the medical device of FIG. 3 after another authorizedaccessory has been attached using a different attachment method than inFIG. 4 . More particularly, in FIG. 4 , the accessory 477 is directlyattached or coupled, for example wirelessly coupled to the medicaldevice 300, while in FIG. 5 , the accessory 577 is coupled through aport 517 on the medical device 300. If the accessory 577 is connectedthrough the port 517, the medical device 300 could use, for example,inductive coupling to transfer connection and authentication informationfrom the accessory to the medical device. Other types of potentialcoupling at the port 517 may include optical coupling, infraredtransmission, or a direct wired connection.

In some embodiments, the accessory 477 or 577 may be a non-invasiveblood pressure hose, a non-invasive blood pressure cuff, an ECG cable,an ECG electrode, pulse oximetry sensor, a respiration sensor, acommunication accessory for transferring patient data, a communicationaccessory for notification of an event, or a communication accessory forinteraction with medical personnel, for instance. If the accessory 477is a patient parameter collecting accessory, the parameter may includecapnography, pulse oximetry, non-invasive blood pressure, ECG with threeor more leads, invasive blood pressure, temperature, heart rate,respiration rate or CPR performance monitoring, for example.

An accessory detector, which may or may not be part of a reader 392determines if an accessory 477 is attached to the medical device 300.After the accessory 477 is attached to the medical device 300,regardless of how the accessory is attached or coupled, the reader 392reads the data set 479 stored in the data storage device 478 of theaccessory 477. The processor 330 uses the data stored within theaccessory data set 479 and read by the reader 392 to determine if apreset authentication criterion is confirmed. The medical device 300, orthe processor 330 within, then uses this determination to control alevel of functionality of the medical device. In some embodiments,instead of the processor 330, an other processor determines whetheroperation of the medical device 300 is to be according to the advancedfunctionality or the basic functionality

In some embodiments, when the accessory 477 is coupled to the housing301, the medical device 300 is capable of the defibrillating and thebasic functionality 352. Further, in some embodiments, the medicaldevice 300 is additionally capable of the advanced functionality onlywhen the accessory 477 is coupled to the housing 301 and it isdetermined that the preset authentication criterion is confirmed. Analternative operation method is for the medical device 300 to not beenabled for advanced functionality 353 until an authorized accessory isattached to it.

When both the basic functionality 352 and the advanced functionality 353are enabled on the medical device 300, oftentimes the functionalitiesdiffer by level of service. For example, the basic functionality 352 ofthe medical device 300 may be to report a first aspect of a parametermonitored through the accessory 477, such as an instantaneous value ofthe monitored parameter, and the advanced functionality 353 may be toreport a second aspect of the monitored parameter, for example a trendof values of the monitored parameter. In another example, the firstaspect may be an instantaneous value of an oxygen saturation reading,and the second aspect is one of carboxyhemoglobin and methemoglobin. Inyet another example, the basic functionality may be to report onprocessing a 3-lead ECG, and the advanced functionality is to report onprocessing ECG based on more leads. In still a further example, thebasic functionality 352 may be to report one of ventricular fibrillationand ventricular tachycardia, and the advanced functionality 353 is toreport on a detected STEMI. In another example, the advancedfunctionality 353 is to provide a full set of data for ST plotting, butthe basic functionality 352 is to provide less than the full set for STplotting. In yet another example the basic functionality 352 is an AEDmode while the advanced functionality 353 is a manual mode.

Other examples of advanced functionality 353 of the medical device 300include an information display functionality, a synchronizedcardioversion therapy, or a pacing therapy.

In some embodiments, to read the data set 479, 579 of the respectiveaccessory 477, 577, the processor 330 of the medical device 300 causes aquery to be transmitted to the accessory. Then, the data set 479, 579 isreceived responsive to the query. In other embodiments, the data set479, 579 is received responsive to attaching the accessory 477, 577 tothe housing 301. In other embodiments, the data set 479, 579 is receivedresponsive to power-on of the medical device 300. In some embodimentsthe data set 479, 579 received from the accessory 477, 577 may beencrypted. In such a case a decryption algorithm is applied by theprocessor 330 to determine whether the received data set confirms theauthentication or does not confirm the authentication.

FIGS. 6A, 6B, and 6C are block diagrams of the medical device 300 ofFIG. 3 after various example unauthorized accessories have beenattached. Unlike the examples described with reference to FIGS. 4 and 5, where an authorized accessory was attached to the medical device 300and the medical device was therefore capable of all of defibrillation351, basic functionality 352, and advanced functionality 353, in FIGS.6A, 6B, and 6C, an unauthorized accessory 677A, 677B, or 677C, isattached to the medical device. In some embodiments of the invention,attaching an unauthorized accessory to the medical device 300 causes themedical device to disable the advanced functionality 353 of the medicaldevice.

Recall from above that the medical device 300 may use various methods toread data from the accessory. The difference with reference to FIGS. 6A,6B, and 6C is that a valid set of data is not received from theaccessory. In the example illustrated in FIG. 6A, the accessory 677Aincludes an accessory data set 679A stored in a data storage device678A, however the data stored in the accessory data set does not satisfythe preset criterion at the medical device 300 to indicate that theaccessory 677A is an authorized device. In the example of FIG. 6B, thereis no data stored in the data storage device 678B, and therefore doesnot satisfy the preset criterion, because there is no data with which tomake the determination. Finally, in the example of FIG. 6C, there is noteven a data storage device present in the accessory 677, thus it isimpossible to read data from such an accessory, and therefore the presetcriterion is also not satisfied.

Thus, in embodiments of the invention, if no data set is received fromthe accessory, such as the accessory 677B or 677C, the authentication isnot confirmed, and the advanced functionality 353 of the medical device300 is disabled or is not enabled. Also, as stated above, if a data set679A is present in the accessory 677A, but the data within the data setdoes not indicate that the accessory is an authorized device, then theadvanced functionality 353 of the medical device 300 is disabled, or isnot enabled.

In addition to disabling the advanced functionality 353 of the medicaldevice 300, the medical device may take additional action when anunauthorized accessory is attached. For example, if the authenticationis not confirmed, the medical device 300 may output a warning, such as awarning to the user that the advanced functionality is disabled becausean unauthorized accessory is being used. Other actions may include themedical device 300 sending a notification to a manufacturer of themedical device if the authentication is not confirmed. In otherembodiments, if the authentication is not confirmed, the medical device300 generates and stores an internal record.

In some embodiments, the advanced functionality 353 of the medicaldevice 300 is enabled, or not disabled, for a limited time after it isdetermined that the preset authentication criterion is not confirmed. Inother words, the advanced functionality 353 of the medical device may beenabled for a period of time, or for a number of operations or eventsbefore becoming disabled. Oftentimes when in this mode the medicaldevice 300 will generate a warning to the user, as described above, toalert the user that the advanced functionality 353 will be disabledbefore or in conjunction with the advanced functionality actually beingdisabled. This affords the user an opportunity to secure an authorizedaccessory and attach it to the medical device 300 without losing theadvanced functionality 353.

Embodiments of the invention are also directed to a control system for amedical device for use with an accessory capable of collecting aparameter of a patient. The medical device is capable of at least abasic functionality, an advanced functionality, and of defibrillatingthe patient. In such an embodiment, the control system may include, forexample, with reference to FIG. 3 , a reader 392 structured to read adata set from the accessory, and a processor 330 coupled to the reader392 and structured to determine whether the data set from the accessoryconfirms or not a preset authentication criterion about the accessory.In some embodiments the function of the reader 392 is included withinthe processor 330. When the accessory is coupled to the housing, themedical device is capable of the defibrillating and the basicfunctionality. Further, the control system is structured to enable theadvanced functionality of the medical device only when the accessory iscoupled to the housing and it is determined that the presetauthentication criterion is confirmed. As described above, the controlsystem may include the reader 392 and processor 330, or the controlsystem may include other components adapted to control the operation ofthe medical device. Some of such components are described with referenceto FIG. 9 below.

FIG. 7 is a conceptual diagram for explaining an operation of accordingto embodiments. In a procedure 730, the medical device 300 determineswhether the attached accessory is authorized or not authorized. If theaccessory is an authorized device, the medical device 300 operates inthe full mode 782, where defibrillation 351, basic functionality 352,and advanced functionality 353 are all possible. If instead theaccessory is not authorized, then the medical device 300 operates inpartial mode 781, where defibrillation 351 and basic functionality 352are possible, but where advanced functionality 353 is not possible.

FIG. 8 is a detailed block diagram showing components of an externaldefibrillator 800 made according to embodiments, which may be anembodiment of the medical device 300 of FIG. 3 . These components canbe, for example, in external defibrillator 100 of FIG. 1 . Plus, thesecomponents of FIG. 8 can be provided in a housing 801, which is alsoknown as casing 801.

External defibrillator 800 is intended for use by a user 880, who wouldbe the rescuer. Defibrillator 800 typically includes a defibrillationport 810, such as a socket in housing 801. Defibrillation port 810includes nodes 814, 818. Defibrillation electrodes 804, 808, which canbe similar to electrodes 104, 108, can be plugged in defibrillation port810, so as to make electrical contact with nodes 814, 818, respectively.It is also possible that electrodes can be connected continuously todefibrillation port 810, etc. Either way, defibrillation port 810 can beused for guiding via electrodes to person 82 an electrical charge thathas been stored in defibrillator 800, as will be seen later in thisdocument.

If defibrillator 800 is actually a defibrillator-monitor, as wasdescribed with reference to FIG. 2 , then it will typically also have anECG port 819 in housing 801, for plugging in ECG leads 809. ECG leads809 can help sense an ECG signal, e.g. a 12-lead signal, or from adifferent number of leads. Moreover, a defibrillator-monitor could haveadditional ports (not shown), such as to receive accessories, and another component 825 for the above described additional features, such aspatient signals.

Defibrillator 800 also includes a measurement circuit 820. Measurementcircuit 820 receives physiological signals from ECG port 819, and alsofrom other ports, if provided. These physiological signals are sensed,and information about them is rendered by circuit 820 as data, or othersignals, etc.

If defibrillator 800 is actually an AED, it may lack ECG port 819.Measurement circuit 820 can obtain physiological signals through nodes814, 818 instead, when defibrillation electrodes 804, 808 are attachedto person 82. In these cases, a person's ECG signal can be sensed as avoltage difference between electrodes 804, 808. Plus, impedance betweenelectrodes 804, 808 can be sensed for detecting, among other things,whether these electrodes 804, 808 have been inadvertently disconnectedfrom the person.

Defibrillator 800 also includes a processor 830. Processor 830 may beimplemented in any number of ways. Such ways include, by way of exampleand not of limitation, digital and/or analog processors such asmicroprocessors and digital-signal processors (DSPs); controllers suchas microcontrollers; software running in a machine; programmablecircuits such as Field Programmable Gate Arrays (FPGAs),Field-Programmable Analog Arrays (FPAAs), Programmable Logic Devices(PLDs), Application Specific Integrated Circuits (ASICs), anycombination of one or more of these, and so on.

Processor 830 can be considered to have a number of modules. One suchmodule can be a detection module 832, which senses outputs ofmeasurement circuit 820. Detection module 832 can include a VF detector.Thus, the person's sensed ECG can be used to determine whether theperson is experiencing VF.

Another such module in processor 830 can be an advice module 834, whicharrives at advice based on outputs of detection module 832. Advicemodule 834 can include a Shock Advisory Algorithm, implement decisionrules, and so on. The advice can be to shock, to not shock, toadminister other forms of therapy, and so on. If the advice is to shock,some external defibrillator embodiments merely report that to the user,and prompt them to do it. Other embodiments further execute the advice,by administering the shock. If the advice is to administer CPR,defibrillator 800 may further issue prompts for it, and so on.

Processor 830 can include additional modules, such as module 836, forother functions. In addition, if other component 825 is indeed provided,it may be operated in part by processor 830, etc.

A reader 892 may be included within the processor 830 as a reader module892, or may be a separate circuit or function. The reader 892 may becoupled to any or all of the defibrillation port 810, the ECG port 819,and any other port that receives an accessory. The reader 892 may readdata from the accessory. Then, the processor 830 may use a module, forexample the other module 836, to determine whether the accessory is anauthorized accessory. The determination may be made based on the dataread from the accessory by the reader 892 and applying the read data toone or more preset authentication criteria. After it is determinedwhether or not the accessory is an authorized one, the processor maycontrol which of the functionalities of the defibrillator 800 to enableor disable.

Defibrillator 800 optionally further includes a memory 838, which canwork together with processor 830. Memory 838 may be implemented in anynumber of ways. Such ways include, by way of example and not oflimitation, nonvolatile memories (NVM), read-only memories (ROM), randomaccess memories (RAM), any combination of these, and so on. Memory 838,if provided, can include programs for processor 830, and so on. Theprograms can be operational for the inherent needs of processor 830, andcan also include protocols and ways that decisions can be made by advicemodule 834. In addition, memory 838 can store prompts for user 880, etc.Moreover, memory 838 can store patient data.

Defibrillator 800 may also include a power source 840. To enableportability of defibrillator 800, power source 840 typically includes abattery. Such a battery is typically implemented as a battery pack,which can be rechargeable or not. Sometimes, a combination is used, ofrechargeable and non-rechargeable battery packs. Other embodiments ofpower source 840 can include AC power override, for where AC power willbe available, and so on. In some embodiments, power source 840 iscontrolled by processor 830.

Defibrillator 800 additionally includes an energy storage module 850.Module 850 is where some electrical energy is stored, when preparing itfor sudden discharge to administer a shock. Module 850 can be chargedfrom power source 840 to the right amount of energy, as controlled byprocessor 830. In typical implementations, module 850 includes one ormore capacitors 852, and so on.

Defibrillator 800 moreover includes a discharge circuit 855. Circuit 855can be controlled to permit the energy stored in module 850 to bedischarged to nodes 814, 818, and thus also to defibrillation electrodes804, 808. Circuit 855 can include one or more switches 857. Those can bemade in a number of ways, such as by an H-bridge, and so on.

Defibrillator 800 further includes a user interface 870 for user 880.User interface 870 can be made in any number of ways. For example,interface 870 may include a screen, to display what is detected andmeasured, provide visual feedback to the rescuer for their resuscitationattempts, and so on. Interface 870 may also include a speaker, to issuevoice prompts, etc. Interface 870 may additionally include variouscontrols, such as pushbuttons, keyboards, and so on. In addition,discharge circuit 855 can be controlled by processor 830, or directly byuser 880 via user interface 870, and so on.

Defibrillator 800 can optionally include other components. For example,a communication module 890 may be provided for communicating with othermachines. Such communication can be performed wirelessly, or via wire,or by infrared communication, and so on. This way, data can becommunicated, such as patient data, incident information, therapyattempted, CPR performance, and so on.

FIG. 9 is a detailed flow diagram illustrating example methods accordingto embodiments of the invention. An example flow 900, which accords toembodiments of the invention, operates within or in conjunction with amedical device for use with an accessory capable of collecting aparameter of a patient and capable of at least a basic functionality, anadvanced functionality, and of defibrillating the patient. In the flow900, after the accessory is coupled to the medical device, a process 904receives a data set from the coupled accessory. Then, a process 908determines whether a data set received from the accessory confirms ornot a preset authentication criterion about the coupled accessory.

If the process 908 determines that the preset authentication criterionabout the coupled accessory is not confirmed, then a process 910disables the advanced functionality and then a process 914 collects thepatient parameter. Instead, if the process 908 determines that thepreset authentication criterion about the coupled accessory isconfirmed, then the patient parameter is collected in the process 914without the advanced functionality ever having been disabled in theprocess 910.

Returning back to the beginning of the flow 900, some of the optionalprocesses that may be present in the flow 900 are illustrated in dashedboxes. Before the data set is received from the coupled accessory in theprocess 904, the accessory may be queried in a process 902. Further, ifthe data set received from the accessory is encrypted, then the data setmay be de-crypted in a process 906. Finally, between the process 910that disables the advanced functionality and the process 914 thatcollects the patient parameter, an optional process 912 generates awarning, for example, to the user, that the advanced functionality hasbeen disabled. In other embodiments, the warning generated in theprocess 912 may be sent as a notification to a manufacturer of thedevice, or may be stored as a record. Other method steps are alsopossible without deviating from the scope of the invention, such as thefunctions and operations of various components described above withreference to the above figures. For instance, other methods mayoptionally include detecting whether the accessory is attached or notattached to the housing.

In this description, numerous details have been set forth in order toprovide a thorough understanding. In other instances, well-knownfeatures have not been described in detail in order to not obscureunnecessarily the description.

A person skilled in the art will be able to practice the presentinvention in view of this description, which is to be taken as a whole.The specific embodiments as disclosed and illustrated herein are not tobe considered in a limiting sense. Indeed, it should be readily apparentto those skilled in the art that what is described herein may bemodified in numerous ways. Such ways can include equivalents to what isdescribed herein. In addition, the invention may be practiced incombination with other systems.

The following claims define certain combinations and subcombinations ofelements, features, steps, and/or functions, which are regarded as noveland non-obvious. Additional claims for other combinations andsubcombinations may be presented in this or a related document.

What is claimed is:
 1. A medical device for an accessory capable ofcollecting a parameter of a patient, comprising: a housing configured tocouple with a remote accessory configured to collect a parameter of apatient; an energy storage module disposed within the housing configuredto store an electrical charge and configured to deliver the electricalcharge to the patient for defibrillating the patient, the medical devicefurther configured to have basic functionality and advancedfunctionality; a processor disposed in the housing and configured todetermine whether a data set received from the remote accessory confirmspreset authentication criterion about the remote accessory, wherein thedata set corresponds to information stored in a memory of the remoteaccessory; and a memory coupled to and accessible by the processor, thememory configured to store authentication and readiness information andto authenticate the accessory.
 2. The medical device of claim 1, inwhich the advanced functionality of the medial device is enabled inresponse to confirming the authentication information against the presetauthorization criterion.
 3. The medical device of claim 2, in which theadvanced functionality of the medical device is enabled for a limitedtime.
 4. The medical device of claim 1, wherein advanced functionalityof the medical device is disabled in response to failing to confirm theauthentication information against the preset authorization criterion.5. The medical device of claim 4, wherein a warning is displayed on adisplay in response to the failing to confirm the authenticationinformation.
 6. The medical device of claim 1, wherein the received dataset is encrypted when received at the medical device.
 7. The medicaldevice of claim 1, wherein the remote accessory comprises an electrode.8. The medical device of claim 7, wherein the electrode comprises anelectrocardiogram electrode.
 9. The medical device of claim 7, whereinthe electrode comprises an defibrillation electrode.
 10. A method in amedical device for use an accessory capable of collecting a parameter ofa patient, comprising: receiving a data set from a remote accessoryconfigured to collect a parameter of a patient; determining whether thedata set confirms a preset authentication criterion about the remoteaccessory; disabling at least one a function of the a medical device inresponse to not confirming determining that the data set receivedagainst does not confirm the preset authentication criterion, whereinthe function comprises reporting an aspect of the parameter; andcollecting at least one patient the parameter while the at least onefunction is disabled.
 11. The method of claim 10, wherein the receivinga of the data set from a the remote accessory comprises communicativelycoupling the remote accessory to the medical device receiving the dataset through a wireless communication channel.
 12. The method of claim10, further comprising, by the medical device, coupling of the remoteaccessory to a processor of the medical device, wherein the remoteaccessory comprises a defibrillation electrode and a memory, and whereinthe data set corresponds to information is stored in the memory.
 13. Themethod of claim 10, wherein the at least one function is enabled priorto confirming the authentication data the determining whether the dataset confirms the preset authentication criterion about the remoteaccessory.
 14. The method of claim 10, further comprising: enabling thefunction after the collecting the parameter; and collecting at least onepatient the parameter again after the enabling the at least onefunctionis enabled.
 15. A control system for a medical device for usewith an accessory capable of collecting a parameter of a patient,comprising: a reader coupled to a medical device and configured to reada data set from a remote accessory coupled to the medical device,wherein the medical device is configured to defibrillate a patient; aprocessor coupled to the reader and configured to determine whether thedata set from the remote accessory confirms a preset authenticationcriterion about the accessory, wherein the processor is furtherconfigured to enable at least one function of the medical device inresponse to determining that the preset authentication criterion isconfirmed and the remote accessory is authenticated.
 16. The controlsystem of claim 15, wherein the at least one function of the medicaldevice is enabled for a limited time.
 17. The control system of claim15, wherein the at least one function of the medical device is disabledin response to failing to confirm the authentication information againstthe preset authorization criterion.
 18. The control system of claim 15,further comprising a decryption module configured to decrypt thereceived data set, wherein the received data set is encrypted whenreceived at the medical device.
 19. The control system of claim 15,wherein the remote accessory comprises an electrode.
 20. The controlsystem of claim 15, wherein the reader comprises a radio-frequencyidentification reader configured to couple the remote accessory to themedical device through a wireless communication coupling.
 21. The methodof claim 10, wherein the remote accessory comprises an electrode. 22.The method of claim 10, wherein the remote accessory comprises adefibrillation electrode.
 23. The method of claim 10, wherein the remoteaccessory comprises an electrocardiogram electrode.
 24. The method ofclaim 10, wherein the remote accessory comprises a pulse oximetrysensor.
 25. The method of claim 10, wherein the medical device comprisesa defibrillator.
 26. The method of claim 10, further comprising:receiving a second data set from a second remote accessory; determiningwhether the second data set confirms the preset authenticationcriterion; and enabling the function in response to determining that thesecond data set confirms the preset authentication criterion.
 27. Themethod of claim 10, further comprising, after the determining that thedata set does not confirm the preset authentication criterion, enablingthe function for a limited time, wherein the disabling occurs after theenabling of the function for the limited time.
 28. The method of claim10, further comprising causing a warning to be displayed on a display inresponse to the determining that the data set does not confirm thepreset authentication criterion.
 29. The method of claim 10, furthercomprising causing a warning to be sent to a manufacturer of the medicaldevice in response to the determining that the data set does not confirmthe preset authentication criterion.
 30. The method of claim 10, whereinthe data set is encrypted when received from the remote accessory, themethod further comprising decrypting the data set.
 31. The method ofclaim 10, further comprising sending a query to the remote accessoryrequesting the data set, wherein the receiving of the data set from theremote accessory is in response to the sending of the query to theremote accessory.
 32. The method of claim 10, wherein the determiningthat the data set does not confirm the preset authentication criterionindicates that the remote accessory is an unauthorized accessory. 33.The method of claim 10, further comprising receiving information thatthe remote accessory is coupled to the medical device, wherein thereceiving of the data set from the remote accessory is in response tothe receiving of the information.
 34. The method of claim 10, whereinthe receiving of the data set from the remote accessory comprisesreading the data set using a reader coupled to the medical device. 35.The method of claim 34, wherein the reader comprises a radiofrequencyidentification reader.